(84 days)
No
The document describes a mechanical plating system for fracture fixation and does not mention any AI or ML components or functions.
Yes
The device is an internal fixation system for fractures, which is a therapeutic intervention.
No
Explanation: The device described is an internal fixation system used for treating fractures, not for diagnosing medical conditions. It is a medical implant used in surgical procedures.
No
The device description explicitly lists physical components such as plates, screws, locking caps, and instruments, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MDS Plating System is for "internal fixation of fractures of various bones". This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of implants (plates, screws, caps, buttons) and instruments used in surgery. These are physical devices implanted or used during a surgical procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze samples (blood, tissue, etc.), or provide information about a patient's health status through in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MDS Plating System is internal fixation of fractures of various bones such as the clavicle, olecranon. humerus, radius, ulna, distal tibia, and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage of material compatible with system implants including titanium alloy and cobalt chromium.
The Low Profile Head Screw is used independently and is internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The MDS Plating System is an internal fixation system intenal fixation of fractures of various bones. The system consists of the following single-use implants:
- Straight (broad and narrow) and pre-contoured plates available in a variety of sizes
- -Screws of various lengths and diameters, some of which are identified in previously cleared premarket notifications (K141493, K161292/K162635, and K162898).
- Locking Caps of various diameters identified in previously cleared premarket notifications -(K141493, K161292/K162635, and K162898).
- Low Profile Head Screws -
- -Threaded cerclage buttons of various diameters used in conjunction with MDS plates to augment fracture stabilization.
Additionally, the system includes single use and reusable instruments.
Materials: Titanium alloy and Stainless Steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula, foot and ankle.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions:
The results of non-clinical (laboratory/performance) testing as well as engineering analysis for subject devices demonstrate that the device is as safe and as effective as the predicates. Substantial equivalence is demonstrated in the performance testing section of the submission by comparing subject and predicated designs, as well as testing according to ASTMF382-99, Standard Test Method for Metallic Medical Bone Plates and ASTM F543-07, Standard Specification and Test Method for Metallic Bone Screws. Comparison of the design, intended use, and testing demonstrate that the MDS Plating System performs as well as the predicate devices and should thereby be considered substantially equivalent.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K143394, K161292/K162635, K141493, K992891, K132502, K140769, K162898
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
December 8, 2017
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized caduceus symbol. To the right of it is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Miami Device Solutions, LLC Michelle Montesino Regulatory Affairs Associate 7620 NW 25th Street. Unit 3 Miami, Florida 33122
Re: K172786
Trade/Device Name: MDS Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: September 14, 2017 Received: September 15, 2017
Dear Michelle Montesino:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name MDS Plating System
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020
See PRA Statement below.
The MDS Plating System is internal fixation of fractures of various bones such as the clavicle, olecranon. humerus, radius, ulna, distal tibia, and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage of material compatible with system implants including titanium alloy and cobalt chromium.
The Low Profile Head Screw is used independently and is internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.
| and in the mail one of the collegend desires the minimal come the many of the may be any and the may be any and | ||
|---|---|---|
| Type of Use (Select one or both, as applicable) | ||
| read analysis and research and any and security of the creative and security and on |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) SUMMARY
| Submitter Name: | Miami Device Solutions, LLC | ||
|---|---|---|---|
| Submitter Address: | 7620 NW 25th Street, Unit 3; | ||
| Miami, FL 33122 | |||
| Contact Person: | Michelle Montesino | ||
| Phone: (786) 422-1400 Ext. 106 | |||
| Fax: (786) 422-1401 | |||
| Anderson Giraldo | |||
| Phone: (786) 422-1400 Ext 115 | |||
| Fax: (786) 422-1401 | |||
| Date of Submission: | 9/14/2017 | ||
| Manufacturer Name: | Miami Device Solutions, LLC | ||
| Manufacturer Address: | 7620 NW 25th Street, Unit 3; | ||
| Miami, FL 33122 | |||
| Registration Number: | 3009222247 | ||
| Contact Name: | Markku Biedermann | ||
| Title: | President | ||
| Device Trade Name: | MDS Plating System | ||
| Device Common Name: | Primary: Plate, Fixation, Bone | ||
| Secondary: Screw, Fixation, Bone | |||
| Classification Names: | Primary: Plate, fixation, bone | ||
| Secondary: Screw, fixation, bone | |||
| Classification Code: | Primary: HRS – Class II | ||
| Secondary: HWC – Class II | |||
| Classification Panel: | Orthopedic | ||
| Regulation Number: | Primary: 21 CFR section 888.3030 – Single/multiple component | ||
| metallic bone fixation appliances and accessories | |||
| Secondary: 21 CFR section 888.3040 – Smooth or threaded metallic | |||
| bone fixation fastener | |||
| Predicate Device: | Primary | K143394 | Acumed Small Fragment Base Set |
| Secondary | K161292/ | ||
| K162635 | Miami Device Solutions Distal | ||
| Radius Plating System | |||
| Plating System | |||
| Secondary | K141493 | Miami Device Solutions Proximal | |
| Humerus Plating System | |||
| Secondary | K992891 | Synthes Cerclage Positioning Pin | |
| Secondary | K132502, | ||
| K140769 | Variax 2 System Bone Screws |
Secondary
Miami Device Solutions Olecranon
4
Reference Devices:
Paragon 28, Inc .; The Monster Screw System: Instrument Reprocessing Instructions for Reusable Instruments – K151418
Device Description:
The MDS Plating System is an internal fixation system intenal fixation of fractures of various bones. The system consists of the following single-use implants:
- Straight (broad and narrow) and pre-contoured plates available in a variety of sizes -
- -Screws of various lengths and diameters, some of which are identified in previously cleared premarket notifications (K141493, K161292/K162635, and K162898).
- Locking Caps of various diameters identified in previously cleared premarket notifications -(K141493, K161292/K162635, and K162898).
- Low Profile Head Screws -
- -Threaded cerclage buttons of various diameters used in conjunction with MDS plates to augment fracture stabilization.
Additionally, the system includes single use and reusable instruments.
Materials: Titanium alloy and Stainless Steel.
Intended Use:
The MDS Plating System is intended for internal fixation of fractures of various bones such as the clavicle, olecranon, humerus, radius, ulna, distal tibia, and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage cable of material compatible with system implants including titanium alloy and cobalt chromium.
The Low Profile Head Screw is used independently and is internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.
Substantial Equivalence Statement:
Documentation is provided which demonstrates that the MDS Plating System is equivalent to its predicate devices in terms of material, design, indications for use, and performance characteristics.
Performance Data:
Non-Clinical Performance and Conclusions:
The results of non-clinical (laboratory/performance) testing as well as engineering analysis for subject devices demonstrate that the device is as safe and as effective as the predicates. Substantial equivalence is demonstrated in the performance testing section of the submission by comparing subject and predicated designs, as well as testing according to ASTMF382-99, Standard Test Method for Metallic Medical Bone Plates and ASTM F543-07, Standard Specification and Test Method for Metallic Bone Screws. Comparison of the design, intended use, and testing demonstrate that the MDS Plating System performs as well as the predicate devices and should thereby be considered substantially equivalent.
Clinical Performance and Conclusions:
5
Clinical data and conclusions were not needed for this device.
Conclusion
The MDS Plating System is substantially equivalent to the predicate devices.